A Heparin Plant? The Belated FDA Inspection Report
The FDA took great pains yesterday to provide an update on the Heparin scandal. You know, that’s one in which a few hundred people reported serious side effects, and four deaths were also linked to the Baxter blood thinner. And then the FDA acknowledged the Chinese plant, which is run by a supplier to Baxter, was never inspected, because of some snafu involving paperwork and incorrect names and who-knows-what-else.
So the latest tidbit revealed by the agency is that the plant was finally inspected. Of course, the stumblebums at the FDA scheduled the teleconference without posting the inspection report on the agency web site, which meant the media couldn’t ask any pertinent questions about the findings. The upshot, however, is that the inspectors found a bunch of problems. What a surprise.
Anyway, this is the report, which in FDA parlance is known as a 483 form. It is, however, redacted, which is typical. Beyond that, the report is unusually brief, but not without disturbing detail. Click on the report to enlarge it or take a gander at a cleaned-up version. Read at your peril.
